FDA Adverse Event
Malfunction
Summary report: N
OPTISEAL VALVED PTFE PEELABLE INTRODUCER
MDR report key: 3181653
·
Received June 14, 2013
Report
- Report Number
- 2183787-2013-00042
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Report Date
- June 14, 2013
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DYB
- PMA / PMN Number
- K093232
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING BIV PPM UPGRADE USED NEW GREATBACH MEDICAL OPTISEAL INTRODUCER, NURSING STAFF DISCOVERED DURING CASE, A PIECE OF PLASTIC FLOATING LOOSE IN THE SYRINGE SIMILAR IN APPEARANCE TO THE TIP OF A SYRINGE. THEY ALSO FOUND A HARD SILVER OF CLEAR LOOKING MATERIAL WHICH THEY ARE NOT SURE WHERE IT CAME FROM BUT THEY BELIEVE IT MAY HAVE COME FROM THE INTRODUCER (THE PART THAT IS SPLIT) AS IT WAS FOUND IN CLOSE PROXIMITY TO THE SLIT INTRODUCER AND SIMILAR IN LENGTH TO THE PORTION THAT IS SLIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271251 | OPTISEAL VALVED PTFE PEELABLE INTRODUCER | OPTISEAL VALVED PTFE PEELABLE INTRODUCER | DYB | GREATBATCH MEDICAL | 1000093-004 | W2248486 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |